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A single center, randomized, parallel, clinical outcome trial to compare the rate of healing in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation) or standard of care sharp debridement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contact Ultrasonic Debridement Device | Active Comparator |
| |
| Standard Sharp Debridement | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contact ultrasonic debridement device | Device | Cavitational ultrasound wound debridement device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete wound closure | 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Relative rate of wound healing | 8, 12 and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oscar M Alvarez, PhD | Director, Wound care Center, Calvary Hospital | Principal Investigator |
| Martin E Wendelken, DPM, RN | Physician, Wound Care Center, Calvary Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calvary Hospital Center for Curative and Palliative Wound Care | The Bronx | New York | 10461 | United States |
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